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MedNess: bite-size biopharma and medtech news

8th July, 2020
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MedNess This Week
HIGHLIGHTS
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Drug Approvals
FDA Approves KEYTRUDA® for 1L Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer Patients Based on Ph 3 KEYNOTE-177 Results
“Today’s approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed KEYTRUDA monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options.”
FDA approves Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
“The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options.”
Tabrecta™ approved in Japan for advanced NSCLC with METex14 based on Ph 2 GEOMETRY mono-1 trial data
“With the remarkable overall response rates seen both in treatment-naive and previously treated patients, we are thrilled that MHLW has added Tabrecta as a new treatment option for patients with advanced NSCLC with METex14,” said Brian Gladsden, President of Novartis Oncology Japan. “Today’s approval reinforces the potential benefit this new MET inhibitor can bring to thousands of patients diagnosed in Japan each year and is a positive step in our journey to transform the lives of patients with lung cancer.”
FDA approves BAVENCIO® (avelumab) for the 1L maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) patients not progressed with platinum-containing chemotherapy
“As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” said Petros Grivas, M.D., Ph.D., one of the principal investigators in the JAVELIN Bladder 100 trial. “With median overall survival of more than 21 months measured from randomization, the longest overall survival in a Phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”
Regulatory News
Betalutin® Receives Fast-Track Designation from US FDA for Marginal Zone Lymphoma
Lars Nieba, Interim Chief Executive Officer, commented: "We are very pleased to receive Fast-track designation for Betalutin® in MZL, which recognizes the clear need for new therapeutic options for patients with advanced MZL patients who no longer respond to the therapies they have been receiving. We are evaluating the opportunity for investigating Betalutin® in this important and underserved indication and will provide an update when we have made a decision."
NDA for Pralsetinib submitted to FDA for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers
"Pralsetinib has broad potential to address the medical needs of patients with RET-altered cancers, who have not traditionally benefited from targeted therapy even though their tumors have a known disease driver," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "There are now pending marketing applications for pralsetinib in RET-altered non-small cell lung cancer and thyroid cancers, supporting our goal to advance treatment standards for these patients. We are working closely with the FDA and aim to bring this promising treatment to patients as expeditiously as possible."
European Medicines Agency (EMA) adopts negative opinion on the MAA for pexidartinib in adult TGCT patients
“We will evaluate feedback received from the Committee in order to determine the appropriate next steps for pexidartinib in the EU. Despite this setback, we continue to believe in the potential of pexidartinib for people with TGCT, who often face debilitating symptoms and currently have no approved systemic treatment option,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.
Trial Results
Very Favorable Topline Results Announces from Ph 2 Tisotumab Vedotin Study in Recurrent or Metastatic Cervical Cancer
“After treatment with first-line chemotherapy regimens, there is a high unmet need for new effective and tolerable treatment options for women with advanced cervical cancer, regardless of biomarkers and histology,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “These promising topline data from innovaTV 204 will be the basis of further engagement with the U.S. FDA as we continue to progress and expand our tisotumab vedotin development program in solid tumors with our partner.”
ESMO GI 2020: Clinical Data from Ph 1/2 Trial of EDP1503 to be Presented
  • Clinical data from Ph 1/2 trial of EDP1503 + pembrolizumab, in MSS CRC, TNBC, and checkpoint inhibitor relapsed tumor patients to be presented
  • In addition to data in MSS CRC patients, preliminary data on 11 TNBC patients (8 on high dose and 3 on low dose EDP1503) to be reported
  • 25% ORR and 37.5% DCR were observed across all TNBC subjects receiving high dose EDP1503
  • Further data from TNBC cohort expected in 4Q 2020
Trial/Program Status
Ph 3 Study Pracinostat AML Trial to be Discontinued after IDMC Interim Analysis
  • Helsinn and MEI Pharma announced the results of an interim futility analysis of the ongoing Ph 3 trial of pracinostat + azacitidine in AML patients unfit to receive standard intensive chemotherapy
  • Interim futility analysis was undertaken by the study Independent Data Monitoring Committee (IDMC)
  • Analysis has demonstrated that Ph 3 trial was unlikely to meet the primary endpoint of OS improvement vs control group
  • Based on the outcome of the interim analysis, patient recruitment is to be discontinued and study to be ended.
  • The decision was based on a lack of efficacy and not on safety concerns.
  • Pending further evaluation, patients currently enrolled in other pracinostat studies will continue treatment.
Ph 1 DS-1062 Study Expanded to Include Patients with Triple Negative Breast Cancer
 “Following the promising preliminary results reported with DS-1062 in patients with non-small cell lung cancer, we have expanded the study to include patients with triple negative breast cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “We continue to follow the science to determine whether DS-1062, designed with our proprietary DXd ADC technology, could serve as a new TROP2 directed therapy option for patients with TNBC and other cancers.”
Click Here for more on Trial/Program Status
Collated by : Richa Tewari, PhD
MedNess Reviews
FDA Approves New HIV Treatment for Patients With Limited Treatment Options
ViiV Healthcare's novel attachment inhibitor Rukobia (fostemsavir) was granted a Fast Track, Priority Review and Breakthrough Therapy designations the U.S. Food and Drug Administration (FDA). For heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, Rukobia can be prescribed in combination with other antiretroviral (ARV) therapies.
 Data from the Phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimised background therapy (OBT) in a clinical trial of 371 HTE adults living with multidrug-resistant HIV, was used to support the approval of Rukobia. On day eighth of treatment with either Rukobia or placebo, in addition to their failing antiretroviral regimen, the group with the Rukobia treatment showed significant reduction in levels of HIV-RNA in their blood compared to those taking the placebo. After 24 weeks of Rukobia plus other antiretroviral drugs, 53 percent of participants continued to have undetectable amount of HIV RNA in their blood, and even after 96 weeks of treatment 60 percent of participants continued to show HIV RNA suppression.
The common side-effects included nausea and elevated liver enzyme levels in case of patients with additional hepatitis B or C infection and immune reconstitution syndrome.
Collated by : Tanmoy Samaddar
Medness Business
Onco-News

Oblique Therapeutics and Targovax enter collaboration to target mutant RAS cancers by combining their ONCOS and Abiprot™ platforms
Dr. Sreesha P Srinivasa, Ph.D., Senior Vice President, Translational R&D Oblique Therapeutics, commented, "We are delighted to partner with Targovax in extending the capabilities of our proprietary AbiprotTM platform to translate antibodies against difficult to reach intra-cellular targets into effective therapeutics. RAS is one of the most frequently mutated oncogenes but has until recently proven to be therapeutically intractable. Oblique has used its AbiprotTM platform to identify novel epitopes on mutant RAS and developed functional antibodies against these epitopes. The ONCOS platform potentially offers an efficient vehicle for intracellular delivery of these functional antibodies into cancer cells. If proven successful, this extends the target space addressable by antibodies to a large number of very important intracellular oncogenes"
G1 Therapeutics and Boehringer Ingelheim to co-promote trilaciclib in the United States and Puerto Rico
“We believe that trilaciclib has the potential to benefit patients with cancer being treated with chemotherapy across a broad range of solid tumors,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. “Our clinical trials of trilaciclib in small cell lung cancer have demonstrated significant myelopreservation benefits, and we are excited to collaborate with Boehringer Ingelheim’s experienced commercial oncology team to bring this innovative therapy to patients with SCLC. In addition, this capital efficient launch structure provides us with the ability to make investments in a robust development program to assess trilaciclib in other solid tumors, including colorectal cancer and breast cancer.”
Ipsen, Exelixis & Roche to conduct Ph 3 CONTACT-01 (cabozantinib + atezolizumab in mNSCLC) and CONTACT-02 trial (of cabozantinib + atezolizumab in mCRPC) patients
“There is a growing body of preclinical and clinical evidence that cabozantinib may positively impact treatment when paired with immunotherapy,” said Dr. Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. “We are pleased to enter into this collaboration with Exelixis and Roche to build on the promising data from COSMIC-021 and further examine the potential of cabozantinib in combination with atezolizumab to treat metastatic non-small cell lung cancer and for men with metastatic castration-resistant prostate cancer.”
PharmaMar receives $100 million from Jazz Pharmaceuticals for the approval of ZepzelcaTM  (lurbinectedin) in the U.S.
  • PharmaMar could receive up to an additional US $150 million when full approval is achieved.
  • Lurbinectedin was approved in the USA last month for the treatment of adult mSCLC patients with disease progression.
  • Jazz Pharmaceuticals to launch ZepzelcaTM in the U.S. in July 2020.
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
Boehringer Ingelheim invests $507.9 million in an External Innovation Hub in China
As announced on July 2nd 2020, Boehringer Ingelheim (BI, Germany) has invested in the creation of an External Innovations hub in China, with the aim of tapping into China’s innovation, research and development opportunities. The company plans on collaborating both by exchange of business development personnel as well as by allowing Chinese academic and biotech institutions access to the Boehringer Ingelheim Venture Fund. BI’s Research Beyond Borders (RBB), Boehringer Ingelheim Venture Fund (BIVF) and Business Development & Licensing (BD&L) arms will be functioning in the new venture.
The new External innovations hub will be built in a span of 5 years. The team at the hub is aiming to achieve 71 approvals in China, either in the form of new products or indication, by the year 2023.
“This innovative business model will provide one-stop shop solutions for innovators in the biopharmaceutical industry in China and Asia by providing access to early stage research collaborations, strategic partnerships across the value chain as well as equity investment to help convert their creative ideas into reality.”- Dr. Weiyi Zhang, Head of Boehringer Ingelheim External Innovation Hub China.

Freeline Therapeutics bags $120 million in series C funding for its AAV based Haemophilia B gene therapy program
Freeline Therapeutics (Freeline, London) announced securing $120 million in series C funding for its proprietary AAV based gene therapy for Haemophila A&B, Fabry Disease and Gaucher Disease. The investment round was led by Syncona that put in $40 million followed by $80 million investment by Novo Holdings A/S, Eventide Asset Management Wellington Management Company, Cowen Healthcare Investments, Acorn Bioventures and Ample Plus Fund. The announcement came in on 30th June 2020.
Freeline’s AAV gene therapy platform consists of viral capsid-borne cell specificity for targeted delivery of the therapeutic protein expression cassette. Their technology allows for high protein expression levels per transduced viral genome, thereby maintaining low viral titers for efficient gene delivery.
The company plans to use the secured funds towards advancing its lead Haemophilia B program into Phase III clinical trial, while pushing its Fabry’s Disease program through Phase 1/2. The money will also be used to advance the Haemophilia A and Gaucher’s Disease programs past preclinical stages.
Click Here for more news and details on mergers, acquisitions and business updates
Collated by : Divyaanka Iyer
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Tanmoy Samaddar
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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Content Editors: Richa Tewari , Esha Sehanobish , Divyaanka Iyer, Arundithi Ananthanarayanan, Debarati Banik, Tanmoy Samaddar, Mayur Vadhvani and Abhinav Dey 
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